QA Coordination and Document Management (55-65%)
- Independently review and triage high volume of incoming requests to QA and assign to QA staff based on area of expertise.
- Independently review high volume of document change requests in the electronic quality management system (eQMS) and assign to QA staff based on area of expertise.
- Perform quality system document reviews using the eQMS and document quality checks as assigned to ensure documents meet the requirements of the QMS.
- Liaise with quality system document owners as required to seek clarity on processes outlined in quality system documents.
- Support QA personnel with publishing quality system documents.
- Provide input to QA department processes to support continuous improvement activities.
QA Audits/Inspection Management (15-20%)
- Assist with external audits and regulatory inspections, which may include preparation for audit/inspection (e.g., schedule audit participants, distribute audit agenda, book and prepare the audit meetings).
- Create audit folder and upload requested documents to shared folder for auditor review.
- Support QA audit team in managing auditor requests during the audit/inspection.
- Generate record/notes of audit discussions and findings.
QA Meetings (10-15%)
- Plan and coordinate QA Department meetings including scheduling and agenda planning.
- Generate QA Department meetings minutes and circulate for review.
- Provide meeting support to QA team members as required.
Additional Knowledge and Skills
- Diploma or bachelor's degree in a related field
- 1 - 3 years of relevant experience
- Quality Assurance or Clinical Research specialty preferred.
- General knowledge of regulations and standards governing global clinical research practices
- Proficiency with MS Office (Word, Excel, Power Point, Outlook and Teams)
- Strong written and verbal communication skills. Strong time management skills.
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